A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs
2 other identifiers
interventional
244
6 countries
28
Brief Summary
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Oct 2009
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
November 27, 2012
CompletedNovember 27, 2012
October 1, 2012
1.7 years
January 14, 2010
July 26, 2012
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Height (cm) Z-score at Study Visit
Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.
One single study visit, approximately one week after informed consent has been obtained
Secondary Outcomes (2)
Age (Years) at Current Tanner Stage
One single study visit, approximately one week after informed consent has been obtained
Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events
Retrospectively during the time of exposure for up to 2 years prior to the study visit
Study Arms (2)
Risperidone
EXPERIMENTALRisperidone as per local prescribing practices
Other atypical antipsychotic drugs
EXPERIMENTALOther atypical antipsychotic drugs as per local prescribing practices
Interventions
As per local prescribing practices
Eligibility Criteria
You may qualify if:
- One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
- Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
- Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
- Had medical records or automated data available for at least 1 year prior to the start of exposure
- Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)
You may not qualify if:
- Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
- Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
- Had exposure to Paliperidone
- Cannot comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Altamonte Springs, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Smyrna, Georgia, United States
Unknown Facility
Naperville, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Valparaiso, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Cambridge, Massachusetts, United States
Unknown Facility
Glen Oaks, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Antwerp, Belgium
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Jena, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
München, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Würzburg, Germany
Unknown Facility
Athens, Greece
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Gdansk, Poland
Unknown Facility
Kielce, Poland
Unknown Facility
Lódź, Poland
Unknown Facility
Sosnowiec, Poland
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A total of 350 subjects in a 1:1 ratio between the two arms was planned. Recruitment difficulties led to an imbalance in the number of subjects per arm and to early termination of the study. The results should be interpreted within this context.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 15, 2010
Study Start
October 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
November 27, 2012
Results First Posted
November 27, 2012
Record last verified: 2012-10